This patent application is related to the invention disclosed in copending, coassigned patent application Ser. No. 830,662 filed Feb. 18, 1986.
This invention relates to compositions and methods employing the same for the treatment and healing of humans. In one embodiment this invention relates to compositions and methods useful for the treatment of viral-associated skin disorders. In another embodiment this invention relates to the treatment of cancerous skin disorders. In yet another embodiment this invention relates to compositions useful for the treatment of humans to dissolve or remove blood clots.
Virus-caused skin disorders are known. Dermatropic viruses are known and include pox virus, measles virus, varicella-zoster virus, coxsackie virus, echovirus, herpes simplex virus, rubella adenovirus, pappilloma virus and molluscum-contagiosum virus. Skin disorders which are caused by viruses include exzema, conjunctivitis, psoriasis, keratoconjunctivitis, gingivostoma, herpes labium, herpes keratitis, genital herpes, chickenpox and shingles. Cancerous skin disorders are also known, such as melanoma, basal cell carcinoma, squamous cell carcinoma and Karposi sarcoma.
Various techniques nave been employed and compositions suggested for the treatment of the above-mentioned skin disorders. For example, surface active agents (surfactants) have been disclosed as being useful for the treatment of viral skin disorders, see U.S. Pat. No. 4,507,281. This patent also discloses that human interferon is advantageously employed in association with an antiviral surfactant in the treatment of herpes simplex viral infections. Interferon, a known antiviral agent, has also been suggested for use in the treatment of leukemia, a form of cancer. Also of interest as disclosing antiviral surfactants are U.S. Pat. Nos. 4,020,183 and 4,139,630.
Biologically active materials are known and have been suggested as being useful for the treatment of humans. For example, tissue plasminogen activator (t-PA), a blood clot dissolver or enzyme which converts or activates plasminogen into plasmin, is known, see, for example, Biotechnology, Vol. 4, August 1986, pp. 706-711 and Genetic Engineering News, Vol. 6, No. 7, July/August 1986, the article entitled "Competition Heats Up to Commercialize tPA for the Treatment of Heart Attack Patients" has been suggested for the treatment of heart attack victims. Other biologically active materials, such as epidermal growth factor (EGF), which stimulates the proliferation of various mammalian cells is known, see Science, Aug. 29, 1986, pp. 975-976. Another useful biological material for the control of proliferation and differentiation and other functions of cells, transforming growth factor-beta (TGF-.beta.), is known, see Science, Aug. 1, 1986, pp. 532-534. TGF-.beta. would appear to have practical application in repair of injury caused by trauma, burns and surgery and debility in the aged, in addition to its ability to promote collagen formation. Other biologically active materials, transforming growth factor-alpha (TGF-.alpha.), TGF-.alpha. and epidermal growth factor (EGF), are structurally related peptides and appear to be angiogenic mediators like epidermal growth factor, see Science, June 6, 1986, pp. 1250-1253. Another biologically active material useful in the practices of this invention is human endothelial cell growth factor (ECGF), see Science, Aug. 1, 1986, pp. 541-545. Still another biologically active material is fibronectin, see U.S. Pat. No. 4,585,654 and Nature, Vol. 321, June 19, 1986, p. /28. Fibronectin, also known as large external transformation sensitive protein (LETS), includes cell surface protein (CSP), cell aldhesion protein (CAP), cold insoluble globulin (CIG) and opsonic alpha 2 surface binding glycoprotein. Yet another biologically active material has been termed granulocyte macrophage colony stimulating factor (GM-CSF). This material has been identified as a glycoprotein of about 24-26,000 daltons and has been produced by employing recombinant genetic engineering techniques, see U.S. Pat. No. 4,230,697, PCT International patent application No. WO 85/04188 published Sept. 26, 1985, and Science, May 17, 1985, pp. 810-814. Of additional interest in connection with colony stimulating factor (CSF) are the publications, J. Exp. Med., Vol. 152, October 1980, pp. 1036-1047, Nature, Vol. 314, Apr. 18, 1985, pp. 625-628, Proc. Natl. Acad. Sci. U.S.A., Vol. 82, March 1985, pp. 1526-1530, Exp. Hematol., Vol. 13, 1985, pp. 249-260, and Blood, Vol. 66, No. 4, 1985, pp. 788-795.
The disclosures of all the above-identified patents and publications and others mentioned hereinafter are herein incorporated and made part of this disclosure.
It is an object of this invention to prepare and utilize compositions containing one or more of the above-identified biologically active materials for the treatment of humans, for example, as antiviral and/or anticancer agents and/or a healing or cell growth agent.
It is another object of this invention to provide techniques for the employment of the above-identified biologically active materials in the treatment of humans.
How these and other objects are achieved will become apparent from the accompanying disclosure. In at least one embodiment of the practices of this invention at least one of the foregoing objects will be achieved.